Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Wednesday, July 29, 2009

Wyeth: Ghostwritten Papers Fake, But Accurate

It looks like Wyeth has lost its battle to keep secret its practices regarding ghostwriting of scientific papers. The issue in question is whether ghostwriting contributed to excessive prescription of post-menopausal hormones and increased the incidence of breast cancer:

LITTLE ROCK, Ark. - A federal judge has ordered the unsealing of thousands of pages of documents pertaining to the ghostwriting practices of Wyeth Pharmaceuticals, which is being sued over hormone-replacement drugs.

U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and the New York Times. Plaintiffs' attorneys presented the papers earlier at trial to show that Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author.

Of course, in addition to the violation of accepted practices of authorship, such as specified by NIH and the International Committee of Medical Journal Editors, among others, such lucky authors get to "count" such papers in their academic portfolios, presumably also in violation of their own institutional policies and guidelines for fair attribution and intellectual honesty, e.g., here. Ghostwriting may also skew the tenure process, providing advantages to the unscrupulous academic over the ethical scientist or scholar. (One wonders about the true percentage of the massive number of papers claimed by some medical academics actually written by the putative first author.)

The ruling came in a case that involves about 8,000 lawsuits that have been combined before Wilson. The lawsuits focus on whether Wyeth hormone-therapy drugs Prempro and Premarin, used to treat symptoms of menopause, have caused breast cancer in some women.

The New Jersey drugmaker, which has major operations in the Philadelphia area, had already turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley (R., Iowa).

How is evidence based medicine possible if just one drug company has sponsored ghostwritten articles in 40 medical journals and other publications? What is the "total mass" of questionable articles now infecting the literature?

Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors.

The documents were shown to jurors at trial but have otherwise been unavailable publicly.

Plaintiffs say ghostwriting is when a drug company conjures up the concept for an article that will counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft a manuscript conveying the company's message, retains a physician to sign off as the author, and finds a publisher to unwittingly publish the work.

There are several layers of dishonesty in this activity, including foreknowledge of scientific deception through fraudulent misrepresentation of authorship by the pharma, dishonesty of the physician who "signs off" as first author, and misrepresentation by the pharma, the writing company and the physician about provenance of the article to scientific publishers.

Drug firms disseminate their ghostwritten articles to their sales representatives, who present the articles to physicians as independent proof that the companies' drugs are safe and effective.

Wyeth attorney Stephen Urbanczyk acknowledged that the articles were part of a marketing effort. But he said that they were also fair, balanced, and scientific.

What business does a lawyer have lecturing the public that the articles were a dishonest marketing effort masquerading as legitimate science, but were "fair and scientific?" How does he know? In addition, the "fake but accurate" excuse is getting quite shopworn. Hopefully, Sen. Grassley will approach ending this ghostwriting practice with vigor.

In fact, this raises another issue. I have written that management of pharma by those lacking biomedical bona fides is, by definition, mismanagement. This is a case in point. Wyeth's President, Board Chair and CEO Bernard Poussot lacks biomedical credentials. Harry Truman said "the buck stops here", but a in the case of scientific ghostwriting, CEO's such as Poussot cannot vouch firsthand for the accuracy and fairness of their company's science. He lacks the expertise. The buck does not stop at his desk; he is dependent on scientific underlings in such matters.

This affair is another instantiation of my belief that pharma is best led by those with relevant scientific expertise such as Merck under clinician-scientist Dr. Roy Vagelos. (It is perhaps not coincidental that Merck became a shadow of its former self under non-scientist Raymond Gilmartin.)

Wyeth, the world's No. 12 pharmaceutical company by sales, is being bought this fall by No. 1 drugmaker Pfizer.

Finally, another ghostwriter of sorts recently died, Sandford Dody (1918-2009). Dody anonymously penned best selling autobiographies of actresses Bette Davis and Helen Hayes, among many other notables. Such ghostwriting is essentially victimless, as opposed to its counterpart in the scientific domain. However, Mr. Dody had an astute observation about the practice, even when there was no trail of diseased or dead bodies.

... Mr. Dody, who died July 4 at the age of 90, found the work spiritually destructive. "After all," he wrote, "how does one become a ghost without dying a little?"

In the case of biomedical ghostwriting, the conspirators all "die a little" in purveying their intellectual dishonesty on a trusting public.

It's too bad some of that same public also dies, and not just a little, as wages of professorial ghostwriting sins.

The acknowledgements are where minor contributions and reviews get placed in an ethically-attributed scientific paper. Anyone who does not understand this, or rationalizes "honorary authorship" or similar workarounds to meaningful attribution does not belong in science.

Finally, scientific ghostwriting must stop. I also believe its conspirators should be excluded from receiving public money for research and excluded from the biomedical literature for a good, long period of time.

9 comments:

While you hopefully know I am sympathetic to a very high percentage of your concerns and views, I do want to object to the notion -- if in fact you are advancing it -- that we can resolve a great number of the problems you identify if only we place medical doctors in positions of authority within the institutions we are concerned with.

If the history and sociology of Western medicine as a profession reveals anything, it is that self-regulation is an unmitigated failure. Of course, it does not follow from this that things could not improve if physicians rather than entrepreneurs were calling the shots (double negative, ugh); this reflects a more careful suggestion that I might be inclined to agree with.

Moreover, I also want to object to the implication that unless one is a medical doctor, one is in no position to judge whether the evidence base is fair and scientific. Of course, expertise matters, but it is, IMO, dangerous to assert that only experts have any business adjudicating the quality of the evidence in any profession or endeavor.

I guess my ultimate point here is that replacing entrepreneurs with medical doctors is by itself no answer to the problems posed by the dominance of rent-seeking in the industries of health and illness. It may or may not even help all that much.

I guess my ultimate point here is that replacing entrepreneurs with medical doctors is by itself no answer

Daniel,

You proceed from a false assumption regarding my post.

What I wrote was "those lacking BIOMEDICAL bona fides."

I am writing of biomedical sciences expertise. That casts a very wide net, including PhD scientists and MD's - MD/PhD's and other science professionals with a wide variety of backgrounds.

Lawyers for McDonald's and those with marketing backgrounds, for example, simply don't have the biomedical expertise to judge the fairness and accuracy of scientific papers on their own. They are dependent on their underlings, e.g., scientists.

I also add that those in-house scientists who may have been behind ghostwriting in any way are going to be biased in favor of the 'fairness and accuracy' of any paper so produced.

it is, IMO, dangerous to assert that only experts have any business adjudicating the quality of the evidence in any profession or endeavor.

My opinion differs. Do you believe true experts have 1) advantages, 2) parity, or 3) disadvantage over laypeople in judging the quality of biomedical papers?

I believe laypeople are at a distinct disadvantage compared to experts. They can judge biomedical papers, of course, with help; just not nearly as well as a seasoned expert. Ignorance is not bliss in biomedicine, and ignorant leaders are not ideal for biomedical R&D organizations.

Thanks for correcting me, but I still disagree quite seriously with the notion that only persons with science backgrounds are qualified to judge the evidence base.

Would you, for example, accept that only persons with advanced training in applied ethics are qualified to render opinions on clinical ethical problems, or even ethical issues relevant to COIs?

I do not accept that. But note that the argument that laypersons are at a distinct disadvantage in judging evidence, reflecting deeply on ethics, or, to take another example close to my heart, producing professional quality historical scholarship (as compared to simply writing about past events), is a more modest claim.

Of course expertise helps, and it matters. But it does not follow from this premise that no one who lacks that expertise is able to or ought to be permitted to judge evidence on a particular question. Intelligent, experienced, able attorneys are often past masters at being able to delve deeply into and assimilate a body of evidence related to matters they are unfamiliar with.

Expertise does matter -- the able attorney would not dare wade into a body of arcana without guidance and perspective of experts. But to say this is no more than to say that expertise is relevant, and it helps. This is the modest claim I agree with. The immodest claim I reject is the notion that having a science background is a sine qua non.

I guess we've kind of gone off topic, but my main point, from an ethical perspective, is that it seems unpersuasive to me to claim that if only we left the business of research to doctors and scientists, the majority of our problems regarding COIs and money in research would go away.

As I suggested, the history and sociology of Western medicine does not support such a claim.

I still disagree quite seriously with the notion that ONLY persons with SCIENCE backgrounds are qualified to judge the evidence base.

I disagree with that statement, too.

My position is that those with BIOMEDICAL backgrounds are BEST qualified to judge the BIOMEDICAL evidence base. Others can do it, with a lot of help and not as well.

...it seems unpersuasive to me to claim that if only we left the business of research to doctors and scientists, the majority of our problems regarding COIs and money in research would go away.

My claim is that if major decision making processes about the SCIENCE of biomedical research were led by those qualified in BIOMEDICINE, there would be SIGNIFICANT GAINS in BIOMEDICAL creativity and productivity and avoidance of ill-informed, BIOMEDICAL creativity-hostile and productivity-hostile decisions.

The time my staffs and I spent explaining biomedical complexities to lay managers in hospitals and pharma, over many years (time my staff and I would not have had to spend, that could have been devoted to more productive uses if the managers had biomedical backgrounds to start with), only to see them often make the wrong, ill-informed decisions anyway, informed my opinion.

Here is just one case study in point. There are others at that site, and on this blog.

I don't disagree with anything you say in your last comment, but it was not entirely clear from the post how far you wanted to take your arguments. For example, you seemed to be criticizing the attorney in the article for judging the quality of the evidence just because he/she was an attorney.

My point was that, without more, asserting that the attorney has no business proffering such a claim simply because they are not a physician or scientists makes too many assumptions about what is needed to make an informed, critical assessment based on medical and scientific evidence. Expertise matters, but it does not follow from this that a nonexpert could not render a perfectly reasonable, educated opinion (less likely, but not impossible).

It appears that you agree with this.

And just for the record, I tend to think there is quite a lot of empirical support for some of the claims I advance as well.

For example, you seemed to be criticizing the attorney in the article for judging the quality of the evidence just because he/she was an attorney.

Indeed, I was.

My point was that, without more, asserting that the attorney has no business proffering such a claim simply because they are not a physician or scientists makes too many assumptions about what is needed to make an informed, critical assessment based on medical and scientific evidence.

Again, I am constraining my argument to BIOMEDICINE. That said, why would anyone believe an attorney or marketing exec without biomedical training or expertise (I presume that is the case here) would be qualified to judge complex biomedical publications for fairness and scientific accuracy firsthand?

When I evaluate NIH grant proposals for merit, I also call into play my expertise in computing and informatics (again, gained via formal education) and sometimes telecommunications (by self study, followed by government exam to demonstrate knowledge, plus years of applied experience as a ham radio enthusiast).

I have a significant biomedical knowledge base, so I know what those who do not are missing. The gaps are significant, especially with regard to evaluating complex and/or subtle biomedical issues.

What evidence do you have that a judgment by a person lacking such backgrounds can be significantly more reliable or even at parity with assessments of those who have biomedical backgrounds?

Further, does not the Dunning-Kruger effect become significantly more of a risk with such people compared to those with proven and demonstrated biomedical expertise?

NIH does not have biomedical laypeople making scientific merit assessments of grant proposals. Why?

Expertise matters, but it does not follow from this that a non-expert could not render a perfectly reasonable, educated opinion (less likely, but not impossible).

I clearly place the odds lower than you do. That said, I ask: does placing such people in charge of biomedical R&D organizations such as pharmas represent state-of-the-art talent management practice to maximize discovery, public benefit and shareholder value, or does it represent something else?

Are there not biomedical experts with the business management experience who would be better picks, especially for an industry in difficulty?

Finally, you did not respond to my link to an actual case study where lack of biomedical expertise caused significant hindrance to R&D and shareholder loss at a major pharma. Do you believe this case and others at that site, and the other cases on this blog, were the exceptions?

This thread has evolved into an interesting back-and-forth on the nature of expertise. I am happy to continue this discussion elsewhere, but I find blog comment threads to be far too limiting on such a complex issue.

To return to the post itself, however, my only point was that replacing entrepreneurs with physicians or scientists is no panacea to ethical problems in the scientific research and medicine.

I expressly noted that doing so may constitute an improvement. You seem to agree.

Amy,

Calm down.

I neither stated nor implied that "non-scientists can judge the scientific validity of scientific research as well as or better than experts in the field."

What I did say is that the mere fact that someone is not a physician or scientist does not in and of itself imply the impossibility that they might form a reasonable, educated opinion on a scientific or medical question.

my only point was that replacing entrepreneurs with physicians or scientists is no panacea to ethical problems in the scientific research and medicine.

Daniel,

I think you had more points than that (as did my post, which delved into biomedical leadership issues and nonscience CEOs' inability to personally vouch for their companies' science), but I agree, this forum is too limited for detailed discussion.

The only thing we agree upon is a bit of useless information, a real world-irrelevant hypothetical: namely, a science dilettante can be helped to understand profoundly complex scientific issues to some extent, and even helped to make decisions based on that judgment, just as a layperson can be taught to take out an appendix or land an airplane. However, when your kid's tummy's hurting or when that jet in New York's engines conked out, I don't think you'd have wanted passenger Joe Sixpack behind the scalpel or at the controls.

What I in fact did write is that the mere fact that someone is not a physician or scientist does not in and of itself imply the impossibility that they might form a reasonable opinion on a scientific or medical question, with assistance. However, that is not optimal. In that way, leadership of biopharma by science dilettantes is, by definition, mismanagement.

My point was that hiring such people in biomedical leadership roles is not state of the art talent management, but something else - let's call it talent mismanagement - but I've written that already.

Finally, I think your views on expertise are contaminated by postmodernism. You need to review the rise of modern science and what made that possible. I recommend Carl Sagan's "The Demon-Haunted World: Science as a Candle in the Dark." Sagan identified many of the current ills that plague our culture and contaminate the advancement of science.

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